We are looking for aSenior Regulatory Affairs Manager/Consultantwith 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.

This is a client dedicated project, without people management responsibility. The role can be home or office based in various European locations.

Key Responsibilities:

• Write CMC sections (23S, 23P, 32S, 32P) and scientific rationales for regulatory submissions and responses
  
• Develop and implement variations strategies based on EU guidelines
  
• Coordinate CMC activities across multiple projects
  
• Liaise with global affiliates and manufacturing sites
  
• Provide project leadership and management
  
• Ensure client satisfaction and project quality
  
• Identify new business opportunities and contribute to proposal preparation
  

Required Qualifications:

• 10+ years of experience in regulatory affairs
  
• Extensive knowledge of CMC writing and variations strategy
  
• In-depth understanding of EU guidelines (Variation, ICH, EMA)
  
• Excellent project management and organizational skills
  
• Strong communication abilities and client management experience
  
• Ability to work independently and as part of a team
  
• Proficiency in English; additional languages are a plus
  

Preferred Qualifications:

• Experience with regulatory agencies (e.g., FDA, MHRA)
  
• Industry-recognized certifications or advanced degrees
  
• Publication history or experience presenting at industry conferences